A Fixed Dose Study of 323U66 SR in the Treatment of Major Depressive Disorder (MDD)

Summary

This is a multi-center, placebo-controlled, randomized, double-blind, parallel-comparison
study to confirm the efficacy of 323U66 Sustained Release (SR) orally administered to
patients with MDD (Major Depressive Disorder) at doses level of 150 mg/day and 300 mg/day
for 8 weeks based on the decrease in MADRS (Montgomery-Asberg Depression Rating Scale) total
score, and to evaluate the safety based on adverse events, clinical laboratory tests and
vital signs.

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Medical and Biotech [MESH] Definitions

Dietary Supplements

Products in capsule, tablet or liquid form that provide essential nutrients, such as a vitamin, an essential mineral, a protein, an herb, or similar nutritional substance. (FDA Backgrounder, June 15, 1993, p2)

Talc

Finely powdered native hydrous magnesium silicate. It is used as a dusting powder, either alone or with starch or boric acid, for medicinal and toilet preparations. It is also an excipient and filler for pills, tablets, and for dusting tablet molds. (From Merck Index, 11th ed)

Polyethylene Glycols

Polymers of ETHYLENE OXIDE and water and their ethers. They vary in consistency from liquid to solid, depending on the molecular weight, indicated by a number following the name. They are used as SURFACTANTS, dispersing agents, solvents, ointment and suppository bases, vehicles, and tablet excipients. Some specific groups are lauromagrogols, nonoxynols, octoxynols and poloxamers.

Calcium Sulfate

A calcium salt that is used for a variety of purposes including: building materials, as a desiccant, in dentistry as an impression material, cast, or die, and in medicine for immobilizing casts and as a tablet excipient. It exists in various forms and states of hydration. Plaster of Paris is a mixture of powdered and heat-treated gypsum.

Bipolar Disorder

A major affective disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission and recurrence.

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